Kornimate/medical-research-clean huggingface dataset:
sma flow patterns in neonatal transfusion

Conditions: Necrotizing Enterocolitis

Summary: this study aims to measure the changes induced by packed red blood cell (prbc) transfusion in the superior mesenteric artery (sma) flow velocity and intestinal oxygenation indices in premature neonates. these changes will be measured in relation to feeding, before and after a blood transfusion. overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (nec) - a condition with significant mortality and long term morbidity. identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

hypothesis: in preterm neonates the anticipated physiologic post-prandial increase in each sma flow and intestinal perfusion is blunted post transfusion. this is worse in sga infants and/or in the presence of a pda. questions: 1) does prbc transfusion alter postprandial sma flow increases and intestinal oxygenation indices in preterm infants receiving enteral feeds? 2) is there a difference in postprandial sma flow and intestinal perfusion changes in recently transfused sga infants compared to aga infants, and in those with and without a pda? primary outcome: post-prandial sma flows changes before and after prbc transfusion. secondary outcomes: pre-post prandial changes in near-infrared spectroscopy (nirs)-measured intestinal oxygenation parameters before and after prbc transfusion.

Eligibility criteria:
inclusion criteria: * prematurity (\<34 completed weeks of gestation at birth) * need for prbc transfusion * feeding at least 30ml/kg/day at the time of transfusion exclusion criteria: * neonates previously diagnosed with gastrointestinal problems such as nec, intestinal perforation or atresia. * infants receiving continuous feeds or less than 30ml/kg/day * major congenital or chromosomal abnormalities or infants unlikely to survive * skin disruption precluding application of sensors
statins and risk of myocardial infarction in real life in france

Conditions: Myocardial Infarction

Summary: the main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (mi) in a real life situation in france


Eligibility criteria:
inclusion criteria: * patients can speak french or english * patients can be interviewed by telephone * place of usual residence in the area of recruitment exclusion criteria: * patients refusing to participate in the study * patients who cannot be reached by telephone * previous history of myocardial infarction

Keywords: statins myocardial infarction case-referent study france
radiomics and radiogenomics of non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: in this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up

non-small cell lung cancers (nsclc) are the first cause of cancer-related deaths. recent guidelines suggest the key role of a wide molecular profile because knowledge of the tumor genotype can enable patients with nsclc to be treated with targeted therapies. in this study, a first group of patients with lung adenocarcinoma (study group), tested for the presence of genetic alterations in egfr, alk, and kras, and with available computer tomography (ct) scans, will be evaluated to create a radiomic signature and assess its association with mutational status and prognosis. then, a second group of patients (validation group) will be enrolled to validate the radiomic signature and the status of the genetic alterations and their association with prognosis. radiomic signature and liquid biopsies will be evaluated in patients positive for genetic alterations at each follow-up step to verify their association with prognosis and response to targeted therapies.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of nsclc * patients candidates for mutational status assessment exclusion criteria: - patients with age \<18 years
a text-based intervention in improving adherence to hormone therapy in patients with stage i-iii hormone receptor positive breast cancer

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Estrogen Receptor Positive Tumor; Progesterone Receptor Positive Tumor; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8

Summary: this trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage i-iii hormone receptor positive breast cancer. women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. a text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.

primary objectives: i. examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (maht-cap) in a randomized control trial (rct) design. secondary objectives: i. conduct mediator analyses of intervention efficacy.. exploratory objectives: i. explore whether age (=\ 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress. outline: phase i: participants attend focus groups on adherence to hormone therapy. phase ii: participants are randomized to 1 of 2 groups. group i: participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (aht) adherence. group ii: participants receive usual care. after completion of study, participants are followed up at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * woman diagnosed with stage i-iii breast cancer (bca). * hormone receptor positive tumor. * completed local definitive treatment (i.e., surgery chemotherapy, radiation). * within 3 month of initiation of a new adjuvant hormonal therapy (aht) regimen. * at least 12 months of aht recommended. * able to read and understand english. * able to provide informed consent. * have a mobile device with text (txt) capability. * know or willing to learn how to use txt. exclusion criteria: • cognitive impairment documented in the electronic medical record (emr), biological variables (sex).
sugammadex vs neostigmine/glycopyrrolate on urinary retention after spine surgery

Conditions: Spine Surgery; Reversal of Neuromuscular Blockade; Urinary Retention Postoperative

Summary: this is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.

subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of neostigmine (50 μg/kg, up to 5 mg maximum dose) plus glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * asa physical status i-iii exclusion criteria: * inability to obtain written informed consent * allergy to medications used in the protocol * known or suspected neuromuscular disorders * significant renal disease with a serum creatinine ≥ 2 mg/dl * significant liver disease * a family history of malignant hyperthermia * history of genitourinary surgery, cancer, or radiation within the last year * currently prescribed urological medications or diuretics * bph or symptoms of bph (interrupted or weak urine stream or wake up to urinate more than two times per night) * history or diagnosis of urinary incontinence or urinary retention * history of ponv with use of scopolamine * use of foley catheter pre- or intra- operatively * perioperative medications that influence micturition (e.g., diuretics or intraoperative anticholinergic medication use other than nmb reversal)

Keywords: urinary retention spine surgery sugammadex neostigmine neuromuscular blockade neuromuscular blockade reversal cholinesterase inhibitors cholinergic agents physiological effects of drugs parasympathomimetic autonomic agents
sleep and type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the primary goal of the study is to determine whether insufficient sleep is associated with poor glycemic control in type 1 diabetic children. secondary goals aim to determine whether salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and somnolence, and whether insufficient sleep is linked to body composition. sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals, in 82 type 1 diabetic children.


Eligibility criteria:
inclusion criteria: - female and male type 1 diabetic children and adolescents who are followed at the woman, mother and child's hospital (hôpital femme mère enfant : hfme) of bron, france. exclusion criteria: * refusal of consent of the parents or the child or the adolescent * pregnancy * concomitant pathology that severly impacts sleep * implanted electrical stimulation device * diagnosis of type 1 diabetes \<1 year

Keywords: sleep glycemic control type 1 diabetes amylase body composition lean overweight obese
long-term safety study of ctx0e03 in subjects who completed pisces iii study

Conditions: Ischemic Stroke

Summary: the purpose of this long-term safety study is to follow up subjects treated with ctx0e03 dp to monitor for delayed oncological, neurological, and ctx0e03 dp-related adverse events and to monitor survival

the goal of this study is to assess the long-term safety of subjects treated with intracerebral ctx0e03 dp as measured by the onset of delayed adverse events of special interest (aesis). aesis are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the safety/project physician is related to ctx0e03 dp.

Eligibility criteria:
inclusion criteria: subjects who have received ctx0e03 dp as part of the active arm in the pisces iii study have provided appropriate written informed consent exclusion criteria: * none
partial modified blair incision on benign tumor parotidectomy scar's characteristics

Conditions: Salivary Gland Tumor

Summary: parotidectomy is the treatment of choice for tumors in the parotid gland, with the modified blair is the most common incision used. in our medical center, the incision is tailored to the size and location of the specific parotid tumor. this retrospective analysis aims to determine the incidence of complications and to assess the relation between the mass and scar characteristics in patients who had undergone parotidectomy.

the scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019 will be evaluated. patients will complete a questionnaire regarding the occurrence of complications.

Eligibility criteria:
inclusion criteria: * age above 18 years during the surgery * clinical diagnosis of a benign parotid pathology exclusion criteria: * a malignant pathology of the parotid gland * unavailable data
comparative study of phototherapy for hyperbilirubinemia

Conditions: Hyperbilirubinemia

Summary: hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. it is a condition in which there is too much bilirubin in the blood. bilirubin is a substance that is naturally released when red blood cells break down. in the early newborn period, multiple factors lead to an abnormally elevated bilirubin level. large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or brain damage. about 6.1% of term newborns and a higher percentage of preterm newborns develop hyperbilirubinemia that requires treatment. initiating treatment depends on many factors, including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the rate of indirect bilirubin rise, and the age of the patient. the goal of treatment is to keep the level of bilirubin from rising to dangerous levels. the bilirubin molecule absorbs light. therefore, treatment of hyperbilirubinemia involves exposure of the baby's skin to special blue spectrum light. phototherapy is globally recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in the neonatal period. this light exposure converts water-insoluble indirect bilirubin to a more easily excreted soluble molecule. over the last five years, several devices have been introduced that emit high intensity light in the blue portion of the visible light spectrum. however, despite frequent use of such therapy, the effectiveness of different phototherapy devices has not been adequately compared. the objective of this study is to compare the efficacy of the blue led fiberoptic phototherapy with the metal halide spot phototherapy versus blue led bank light phototherapy versus a combination of tandem therapy on lowering to total serum bilirubin.


Eligibility criteria:
inclusion criteria: * \> 23 0/7 weeks gestation * \> 500 grams * non-hemolytic or presumed physiologic jaundice (within the first 14 days of life) exclusion criteria: * known congenital infection (proven bacterial or viral etiology) * known hemolytic diseases such as but not limited to abo or rh incompatibility, minor blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, or hereditary red blood cell membrane defects (coombs or dat positive) * suspected genetic, syndromic, or hepatic disorder-
uspio enhanced mr imaging in cns tumours (umic)

Conditions: Vestibular Schwannoma; Glioma, Astrocytic

Summary: the immune response or inflammation is known to be a key driver of progression and growth in many solid tumours. inflammatory cells called macrophages are present in high numbers in many brain tumours and these tumour associated macrophages or tam are thought to have prognosis and treatment implications in these tumours. a key question, however, is how this inflammation or tam abundance can be detected, measured and monitored in the clinic. a clinically applicable imaging test that can directly and accurately measure tumour macrophage content would be of considerable value and one technique that may provide this is uspio enhanced magnetic resonance imaging (mri). following intravenous injection, uspio or ultrasmall superparamagnetic iron oxide nanoparticles, circulate in the bloodstream before being taken up by inflammatory cells/macrophages in tumour tissue, wherein they can be detected by mri. this pilot study is to evaluate if a commercially available uspio preparation called ferumoxytol (feraheme ©) can accurately quantify macrophage abundance in brain tumours, with an exploratory focus on vestibular schwannoma (vs) and suspected transforming low-grade glioma (lgg). patients with both non-growing (static) and growing vs, and patients with suspected transforming lgg will undergo dedicated mri sequences before, immediately after (\< 2 hours) and at both 24 and 48hrs after ferumoxytol administration. in patients undergoing surgery, acquired imaging will be compared with resected tumour tissue so that markers of inflammation can be compared with uspio uptake. through advanced laboratory methods this study will seek to establish within resected vs and lgg specimens: the cellular destination/s of uspio uptake; the nature of the inflammatory and/or tumour cells containing the uspio; and the relationship between uspio uptake and tumour blood vessel permeability or leakiness.


Eligibility criteria:
inclusion criteria: * be at least 16 years old * have a cns tumour suspected to be one of the defined histological types (vestibular scwhannoma or low grade glioma) * be able to lie still for up to 1 hour comfortably * opinion of the treating clinician is that the patient will be able to successfully complete the research imaging protocol. exclusion criteria: * life expectancy less than 1 year * previous cns radiotherapy/ stereotactic radiosurgery (srs) * females who are pregnant/ breastfeeding * patients with an egfr \< 30ml/min * patients with known and documented history of iron overload/haemosiderosis/ haemochromatosis * patients with immune or inflammatory conditions e.g. systemic lupus erythematous, rheumatoid arthritis * patients with absolute (e.g. pacemaker) and relative (anxiety or claustrophobia) contraindications to mr scanning * patients with a history of allergic reaction to iron or dextran * patients with a history of allergic reaction to gadolinium contrast agents, asthma or renal problems * patients who are unable to adequately understand verbal explanations or written information given in english.
chinese medicine treatment of obesity with type 2 diabetes, dyslipidemia

Conditions: Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM

Summary: with metformin for the control, evaluate the safety and efficacy of jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia

waist circumference, body mass index, triglycerides, glycosylated hemoglobin, blood glucose were evaluated; liver function, kidney function, blood, urine, stool, adverse event recording, evaluation of low blood sugar event log security.

Eligibility criteria:
inclusion criteria: 1. signed informed consent; 2. waistline male ≥ 90cm, female ≥ 80cm; 3. according to the 1999 who standards, meet diagnostic criteria for type 2 diabetes onset and untreated patients, after a screening period (diet + exercise therapy 4 weeks) after the fasting plasma glucose ≥ 7.0mmol • l-1, but fasting blood glucose \<13.9mmol • l-1, or 2h postprandial blood glucose ≥ 11.1mmol • l-1; and glycated hemoglobin ≥ 7.0%; 4. after a screening period (diet + exercise therapy 4 weeks) after the triglyceride (tg) ≥ 1.7mmol / l, and tg \<5.65mmol / l; 5. tcm for the heat of the gastrointestinal; 6. age 30-65 years old. exclusion criteria: 1. patients has been used insulin therapy; previously had a continuous period of 3 months or longer treatment of diabetes(including other chinese and western medicine, physical therapy, psychological therapy and health food, etc.) ; enrolled within 1 month before the use of blood glucose and lipids drug treatment; 2. patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases; 3. patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmhg or (and) diastolic blood pressure ≥ 100mmhg persons; 4. patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections; 5. patients with mental illness; 6. pregnancy, pregnancy or breast-feeding women to prepare; 7. patients with chinese medicine allergies; and allergy; 8. patients with had participated in this study within 1 month have participated or are participating in other clinical studies; 9. in the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence; 10. according to the researchers to determine, with the possibility of lower income group or the other into a complex set of diseases or conditions, such as work environment, frequent changes in unstable living environment, the situation could easily lead to lost; 11. patients taking the dose and type of antihypertensive drugs can not remain stable; 12. patients taking drugs that affect the quality of the body or health food. 13. patients with liver, impaired renal function (alt, ast greater than 2 times the upper limit of normal; serum creatinine greater than the upper limit of normal); 14. patients are known to lower blood sugar for those who are asymptomatic.

Keywords: type 2 diabetes obesity hypertriglyceridemia
a phase 2 study of berberine ursodeoxycholate (htd1801) in patients with type 2 diabetes inadequately controlled with diet and exercise

Conditions: Type 2 Diabetes Mellitus

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (htd1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.

this phase 2 randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of htd1801 compared to placebo after 12-weeks of treatment. to ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. following this period, patient eligibility will be reassessed. eligible patients will be randomized 1:1:1 to receive htd1801 500 mg twice daily (bid), htd1801 1000 mg bid, or placebo bid.

Eligibility criteria:
key inclusion criteria: * have been diagnosed with type 2 diabetes mellitus according to the 1999 world health organization (who) criteria * have followed dietary and exercise interventions for at least 8 weeks prior to screening * have hba1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization) * have fasting plasma glucose \<13.9 mmol/l (screening and pre-randomization) * have a body mass index ≥18 kg/m\^2 to ≤40 kg/m\^2 key exclusion criteria: * have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by cushing's syndrome or acromegaly, etc.) * have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening * have had 2 or more grade 3 hypoglycemic events within 12 months prior to screening * have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening * have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening * have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening * have used any glucose-modifying medications within 8 weeks prior to screening * have had weight gain or loss ≥5% from screening to randomization